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U.S. Department of Health and Human Services

Safety

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Risperdal (risperidone) Apr 2003

Audience: Neuropsychiatric healthcare professionals

Janssen Pharmaceutica and FDA revised the WARNINGS section of the prescribing information for Risperdal (risperidone), indicated for the treatment of schizophrenia. Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis.

[April 16, 2003 - Letter - Janssen Pharmaceutica]